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Method of in situ formation of translumenally deployable heart valve support

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Method of in situ formation of translumenally deployable heart valve support


A method of implanting a prosthetic valve within the heart comprises translumenally advancing a prosthetic valve comprising an inflatable structure to a position proximate a native valve of the heart. A first chamber of the inflatable structure is inflated and then, independently, a second chamber of the inflatable structure is inflated.
Related Terms: Implant In Situ Lumen Prosthetic Inflate Heart Valve

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USPTO Applicaton #: #20130041458 - Class: 623 21 (USPTO) - 02/14/13 - Class 623 
Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor > Heart Valve

Inventors: Randall T. Lashinski, Gordon B. Bishop

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The Patent Description & Claims data below is from USPTO Patent Application 20130041458, Method of in situ formation of translumenally deployable heart valve support.

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PRIORITY INFORMATION

This application is a continuation of U.S. patent application Ser. No. 11/579,723, filed Dec. 1, 2008, which is the U.S. National Phase under 35 U.S.C. §371 of International Application No. PCT/US2005/015617, filed May 5, 2005 (published as WO 2005/107650 and herein incorporated by reference), which claims the priority benefit of (1) U.S. Provisional Application No. 60/568,402, filed May 5, 2004, (2) U.S. Provisional Application No. 60/572,561, filed May 19, 2004, (3) U.S. Provisional Application No. 60/581,664, filed Jun. 21, 2004, (4) U.S. Provisional Application No. 60/586,054, filed Jul. 7, 2004, (5) U.S. Provisional Application No. 60/586,110, filed Jul. 7, 2004, (6) U.S. Provisional Application No. 60/586,005, filed Jul. 7, 2004, (7) U.S. Provisional Application No. 60/586,002, filed Jul. 7, 2004, (8) U.S. Provisional Application No. 60/586,055, filed Jul. 7, 2004, (9) U.S. Provisional Application No. 60/586,006, filed Jul. 7, 2004, (10) U.S. Provisional Application No. 60/588,106, filed Jul. 15, 2004, (11) U.S. Provisional Application No. 60/603,324, filed Aug. 20, 2004, (12) U.S. Provisional Application No. 60/605,204, filed Aug. 27, 2004 and (13) U.S. Provisional Application No. 60/610,269 filed Sep. 16, 2004, the entire contents of which are hereby incorporated by reference herein. This application is also a continuation of U.S. patent application Ser. No. 11/775,834, filed Jul. 10, 2007, which is a continuation of U.S. patent application Ser. No. 11/122,978, filed May 5, 2005, now U.S. Pat. No. 7,445,630, which claims the priority benefit of (1) U.S. Provisional Application No. 60/568,402, filed May 5, 2004, (2) U.S. Provisional Application No. 60/572,561, filed May 19, 2004, (3) U.S. Provisional Application No. 60/581,664, filed Jun. 21, 2004, (4) U.S. Provisional Application No. 60/586,054, filed Jul. 7, 2004, (5) U.S. Provisional Application No. 60/586,110, filed Jul. 7, 2004, (6) U.S. Provisional Application No. 60/586,005, filed Jul. 7, 2004, (7) U.S. Provisional Application No. 60/586,002, filed Jul. 7, 2004, (8) U.S. Provisional Application No. 60/586,055, filed Jul. 7, 2004, (9) U.S. Provisional Application No. 60/586,006, filed Jul. 7, 2004, (10) U.S. Provisional Application No. 60/588,106, filed Jul. 15, 2004, (11) U.S. Provisional Application No. 60/603,324, filed Aug. 20, 2004, (12) U.S. Provisional Application No. 60/605,204, filed Aug. 27, 2004 and (13) U.S. Provisional Application No. 60/610,269 filed Sep. 16, 2004, the entire contents of the above-referenced applications are hereby incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to medical methods and devices, and, in particular, to methods and devices for percutaneously implanting a stentless valve having a formed in place support structure.

2. Description of the Related Art

According to recent estimates, more than 79,000 patients are diagnosed with aortic and mitral valve disease in U.S. hospitals each year. More than 49,000 mitral valve or aortic valve replacement procedures are performed annually in the U.S., along with a significant number of heart valve repair procedures.

The circulatory system is a closed loop bed of arterial and venous vessels supplying oxygen and nutrients to the body extremities through capillary beds. The driver of the system is the heart providing correct pressures to the circulatory system and regulating flow volumes as the body demands. Deoxygenated blood enters heart first through the right atrium and is allowed to the right ventricle through the tricuspid valve. Once in the right ventricle, the heart delivers this blood through the pulmonary valve and to the lungs for a gaseous exchange of oxygen. The circulatory pressures carry this blood back to the heart via the pulmonary veins and into the left atrium. Filling of the left atrium occurs as the mitral valve opens allowing blood to be drawn into the left ventricle for expulsion through the aortic valve and on to the body extremities. When the heart fails to continuously produce normal flow and pressures, a disease commonly referred to as heart failure occurs.

Heart failure simply defined is the inability for the heart to produce output sufficient to demand. Mechanical complications of heart failure include free-wall rupture, septal-rupture, papillary rupture or dysfunction aortic insufficiency and tamponade. Mitral, aortic or pulmonary valve disorders lead to a host of other conditions and complications exacerbating heart failure further. Other disorders include coronary disease, hypertension, and a diverse group of muscle diseases referred to as cardiomyopathies. Because of this syndrome establishes a number of cycles, heart failure begets more heart failure.

Heart failure as defined by the New York Heart Association in a functional classification. I. Patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. II. Patient with cardiac disease resulting in slight limitation of physical activity. These patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. III. Patients with cardiac disease resulting in marked limitation of physical activity. These patients are comfortable at rest. Less than ordinary physical activity causes fatigue palpitation, dyspnea, or anginal pain. IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

There are many styles of mechanical valves that utilize both polymer and metallic materials. These include single leaflet, double leaflet, ball and cage style, slit-type and emulated polymer tricuspid valves. Though many forms of valves exist, the function of the valve is to control flow through a conduit or chamber. Each style will be best suited to the application or location in the body it was designed for.

Bioprosthetic heart valves comprise valve leaflets formed of flexible biological material. Bioprosthetic valves or components from human donors are referred to as homografts and xenografts are from non-human animal donors. These valves as a group are known as tissue valves. This tissue may include donor valve leaflets or other biological materials such as bovine pericardium. The leaflets are sewn into place and to each other to create a new valve structure. This structure may be attached to a second structure such as a stent or cage or other prosthesis for implantation to the body conduit.

Implantation of valves into the body has been accomplished by a surgical procedure and has been attempted via percutaneous method such as a catheterization or delivery mechanism utilizing the vasculature pathways. Surgical implantation of valves to replace or repair existing valves structures include the four major heart valves (tricuspid, pulmonary, mitral, aortic) and some venous valves in the lower extremities for the treatment of chronic venous insufficiency. Implantation includes the sewing of a new valve to the existing tissue structure for securement. Access to these sites generally include a thoracotomy or a sternotomy for the patient and include a great deal of recovery time. An open-heart procedure can include placing the patient on heart bypass to continue blood flow to vital organs such as the brain during the surgery. The bypass pump will continue to oxygenate and pump blood to the body\'s extremities while the heart is stopped and the valve is replaced. The valve may replace in whole or repair defects in the patient\'s current native valve. The device may be implanted in a conduit or other structure such as the heart proper or supporting tissue surrounding the heart. Attachments methods may include suturing, hooks or barbs, interference mechanical methods or an adhesion median between the implant and tissue.

Although valve repair and replacement can successfully treat many patients with valvular insufficiency, techniques currently in use are attended by significant morbidity and mortality. Most valve repair and replacement procedures require a thoracotomy, usually in the form of a median sternotomy, to gain access into the patient\'s thoracic cavity. A saw or other cutting instrument is used to cut the sternum longitudinally, allowing the two opposing halves of the anterior or ventral portion of the rib cage to be spread apart. A large opening into the thoracic cavity is thus created, through which the surgical team may directly visualize and operate upon the heart and other thoracic contents. Alternatively, a thoracotomy may be performed on a lateral side of the chest, wherein a large incision is made generally parallel to the ribs, and the ribs are spread apart and/or removed in the region of the incision to create a large enough opening to facilitate the surgery.

Surgical intervention within the heart generally requires isolation of the heart and coronary blood vessels from the remainder of the arterial system, and arrest of cardiac function. Usually, the heart is isolated from the arterial system by introducing an external aortic cross-clamp through a sternotomy and applying it to the aorta to occlude the aortic lumen between the brachiocephalic artery and the coronary ostia. Cardioplegic fluid is then injected into the coronary arteries, either directly into the coronary ostia or through a puncture in the ascending aorta, to arrest cardiac function. The patient is placed on extracorporeal cardiopulmonary bypass to maintain peripheral circulation of oxygenated blood.



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Implant delivery and deployment system and method
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Prosthesis (i.e., artificial body members), parts thereof, or aids and accessories therefor
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stats Patent Info
Application #
US 20130041458 A1
Publish Date
02/14/2013
Document #
13648190
File Date
10/09/2012
USPTO Class
623/21
Other USPTO Classes
International Class
61F2/24
Drawings
99


Implant
In Situ
Lumen
Prosthetic
Inflate
Heart Valve


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